Tumors commonly develop in the large intestine of an individual, thereby requiring the surgical removal of a section of the bowel and the rectum and the surgical formation of an artificial rectal opening or stoma. Such a surgical procedure is called a colostomy.
The stoma does not have a sphincter muscle, which permits a person to voluntarily open and close the rectum. Accordingly, a colostomy patient cannot control the opening and closing of the stoma, which is therefore always open and, hence, susceptible to discharge without warning and without the patient's control.
In order to avoid involuntary bowel movement through the stoma, it is customary and desirable for the patient to periodically irrigate the bowel by taking an enema through the stoma. The bowel is normally irrigated on a daily basis, or perhaps every second day, in order to inhibit involuntary discharges.
In general, the irrigation system employed consists of a water reservoir and means for suspending it at about shoulder level to supply gravity flow of the water through a tube leading from the reservoir to the stoma. A plastic sleeve is adapted to be attached to the patient by, for instance, a supporting belt. An opening at or near the upper end of the sleeve encircles the stoma of the patient. A sealing member associated with the opening forms a fluid-tight seal with the abdominal wall of the patient to protect the patient from spilling or soiling during an irrigation operation. The lower end of the sleeve is open for discharge of the irrigating fluid and waste into a toilet or other receptacle. Provision is made at the upper end of the sleeve for ducting the irrigating fluid through the sleeve and into the stoma.
There are two basic types of irrigation sleeves. One is adapted for use in connection with the open method of irrigation and the other is adapted for use in connection with the closed method of irrigation.
Sleeves adapted for use in connection with the open method are provided with open upper and lower ends. They are also provided with an opening in an inner sidewall a short distance below the open upper end. The open upper end permits the patient to insert his hand into the top of the sleeve for manipulation of a catheter tube or cone through the opening in the inner sidewall and into the stoma prior to supplying irrigating fluid to the stoma through the cone or catheter. Some form of closure means, such as a clip or other device, is employed to close the upper end of the sleeve after the cone or catheter tube is withdrawn at the conclusion of the introduction of irrigating fluid to the bowel through the stoma. The sleeve, with its inner sidewall opening in registry with the stoma, is held in place on the patient by an annular body frame or plate secured by a belt about the patient's waist. One such open system is disclosed in U.S. Pat. No. 3,910,274.
For use in connection with the closed method, the lower end of the sleeve is open. The upper end is, however, closed. A closed irrigation system is usually preferred over an open irrigation system, because the closed system inhibits spilling, splashing, and soiling by inadvertent escape of irrigating fluid or waste through the upper end of the sleeve. The closed system also inhibits the escape of offensive odors. Moreover, in an open system, some form of clip or a similar device is required to close the open upper end of the sleeve, and the attachment of these devices to the sleeve presents a practical problem for the patient.
As indicated above, the introduction of the irrigating fluid into the stoma is made by means of a soft flexible catheter tube or a smooth cone. In the closed method, the catheter tube or cone may be passed through an opening in the outer sidewall of the sleeve, this opening being in registry with the opening surrounding the stoma. Some form of seal or flap is provided in the outer sidewall to prevent the irrigating fluid from escaping through the opening therein as it returns to the sleeve at the completion of the irrigation operation. Such arrangements are shown, for example, in U.S. Pat. Nos. 3,292,625; 3,830,235; and 4,050,461.
Until several years ago, only the catheter method of irrigation was available. More recently, the cone method has been supplanting the catheter method because of its many advantages, such as avoidance of bowel injury and more efficient irrigation performance. When, however, it is desired to use a cone rather than a catheter tube, a much larger opening is required in the outer sidewall of the sleeve, thereby complicating the formation of a fluid-tight seal between the sleeve and the cone to prevent leakage. U.S. Pat. No. 3,830,235 discloses a closed irrigation system which utilizes a cone formed integrally with a sleeve in order to avoid leakage around the cone. The irrigation system of U.S. Pat. No. 3,830,235 is disadvantageous because the cone complicates cleaning of the sleeve. In U.S. Pat. No. 4,050,461, there is disclosed a closed irrigation system in which a cone is removeably attached to a closed sleeve. Because a separate clamping device is required for attaching the cone to the sleeve, the irrigation system of U.S. Pat. No. 4,050,461 is expensive to manufacture and time-consuming to employ. The clamping device also makes the system bulky and cumbersome, thereby rendering it uncomfortable. The flexibility of the cone is important to maximize comfort. Because the cone must be sufficiently rigid to be threaded, its flexibility is severely limited.
Many irrigation sleeves for colostomy patients have, in the past, been designed with straight sidewalls. These straight sleeves, which are shown in U.S. Pat. Nos. 3,292,625; 3,672,370; 3,830,235; and 4,050,461, have two basic disadvantages. First, because they have relatively wide lower ends, relatively large clamps or other sealing devices must be employed in order to close off the lower ends after an irrigation operation. Also, the relatively wide lower ends inhibit the ability of these sleeves to direct the discharged irrigating fluid and waste material into an appropriate receptacle.
Tapered irrigation sleeves, such as the one disclosed in U.S. Pat. No. 3,910,274, have been developed to overcome the problems and disadvantages of the straight irrigation sleeves. However, because the taper of these prior art sleeves extends along substantially their entire length, including the lower ends thereof, these problems and disadvantages are not completely overcome. For instance, because irrigation sleeves are commonly cut to a length which is dependent upon the height of the colostomy patient and/or the height of the receptacle into which the discharged irrigating fluid and waste material are supplied, the sleeves can, in certain situations, be cut so short that their lower ends have a width which approaches the width of the straight sleeves. In such situations, the desirous benefits of having an irrigation sleeve with a relatively narrow lower end would be lost or at least impaired. For example, inasmuch as the shortening of these sleeves changes the width of their lower ends, a variety of different sized clamps may be required in order to close off the lower ends.
It has also been common practice to provide irrigation sleeves with a pair of openings, one opening being adapted to receive the stoma and the other opening being adapted to receive a cone or catheter tube. Because the openings are normally located directly across from each other, the cone or catheter tube, after its removal from the stoma at the conclusion of the introduction of the irrigating fluid to the bowel, is in the flow path of the irrigating fluid and waste material being discharged from the stoma. Thus, the cone or catheter tube can become soiled, thereby requiring its cleaning. If, in order to prevent the soiling of the cone or catheter tube, it is detached from the sleeve, there is a real possibility that discharged irrigating fluid and waste material may escape from the sleeve along with offensive odors.